BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK AVIVA TEST STRIPS

    MDR report key: 1011718 · Received March 10, 2008

    Report

    Report Number
    1823260-2008-02263
    Event Type
    Malfunction
    Date Received
    March 10, 2008
    Date of Event
    February 28, 2008
    Report Date
    March 10, 2008
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K043474
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER STATES THE AVIVA STRIP VIAL REPORTS THE EXPIRATION DATE AS 10/31/08. MANUFACTURER REPORTS EXPIRATION DATE AS 10/31/07. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK AVIVA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS - LFR LFR ROCHE DIAGNOSTICS 300244

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR HUMALOG - 1 UNIT/HOUR